Newly Founded Medical Device Company Recognized as One of the Top 50 Most Innovative Medical Technology Startups Worldwide in 2018

A Board of Directors could not decide on the value of technology for a new application. The market was large (>60 M people). But many companies failed to get traction from key opinion leaders. Moreover, the track record of securing reimbursement was poor, taking companies many years after FDA approval.

Applied rigorous analysis of the market and other companies’ experiences, to develop a vision and strategy to navigate the challenges of new therapy development. By gaining trust, convinced the Board to establish a new company. Through influential leadership, orchestrated technology transfer and licensing. Demonstrated value and addressed initial concerns of Key Opinion Leaders, establishing a critical relationship. Developed a reimbursement strategy.

The new company was recognized as one of the Top 50 most innovative worldwide by MedTech Innovator in 2018. Ten top-notch nationally-recognized hospitals and clinics including Beth Israel (Harvard medical school), Mayo Clinic, Northwestern University, Washington University, and others became therapy investigators in a clinical trial as well as technology supporters. Received CMS reimbursement coverage for the device and procedure while in clinical trialsbefore FDA approval.

Clearly Demonstrated Value Positions Company for $78M Acquisition

The company had 12 months of cash left and needed to be acquired. However, the capital structure required a valuation of $30M and comparable transactions ranged from as little as $20M to as much as $40M. Management had not been successful in convincing investors of a value greater than $20M. Redefined the value proposition of the company from technical features to impact on the market and the key market players. Gathered data and information to independently verify the market and clinical benefits of the technology. Clearly demonstrated and verified the impact of the technology on market share of potential investors and strategic fit. The efforts led to the $78M acquisition of the company by Boston Scientific.

Direct-To-Consumer Marketing More Than Doubles The Number of Patients Using Medical Device Technology

Millions of people were diagnosed with a disease, but clinics and hospitals struggled to recruit patients. Most patients in physicians’ or clinics’ databases were either already treated with different approaches or didn’t want to have an invasive treatment. Additionally, the device was in clinical trials (not FDA-approved) and patients had a 50% chance to receive the placebo. Finally, clinicians were under time pressure and could not answer all the questions about the technology.

Developed a comprehensive rigorous approach to drive interested patients to selected clinical sites. Analyzed cost effectiveness of different advertising platforms (Facebook, Google, radio and TV commercials, and print advertising). Designed a step-by-step recruiting process of Facebook ads, electronic and phone patients prescreening, initial patient education and awareness of the technology, introduction of patients to clinical sites. Designed all marketing materials including ads, website, patients’ flyers, posters, and so on.

As a result, selected clinical sites received interested pre-screened patients who were knowledgeable about the therapy. It allowed physicians to spend time on answering their remaining questions and improved clinics’ patients recruitment efficiency. 55% of all patients came through DTC advertising, more than doubling the speed of therapy penetration.

New Company Recruits Top KOLs from Major Universities and Hospitals

A new company did not have relathipship with any physicians. One doctor in the world had experience with the product 8 years ago. Now the company needed to bring 10 well-known hospitals and Key Opinion Leaders (KOLs) who would dedicate time and effort to study the therapy and present it through key society meetings. In addition, the company wanted a clinical advisory board for creadibility and clinical insights. With a lot of failures in the past with other technologies physicians were particularly sceptical.

Identified the targeted KOLs based on publications, their track record, and their relationship with strategic players/potential acquirers. Properly positioned the new technology with KOLs. Articulated the benefits to patients and addressed intial physicians’ concerns. Built relationships.

Past-president of a major medical society agreed to serve as Chairman of the company’s advisory board, and became critical in interactions with FDA. Not only was it a big win for the company, but after a year of work he decided to provide his name and his time to us free of any charge. The company was also successful in recruiting 100% of its targeted KOLs and brought 10 top-notch clinics such as Beth Israel Hospital (Harvard medical school), Mayo Clinic, Norhtwestern University, Stanford university, Washington University, University of Southern California, and others to work with it.

New Decision Process Boosts Innovation and Reverses Market Share Decline

The business was steadily losing market share while R&D expenses were double all of the competition combined. The General Manager position within the business had been open for more than nine months and executives did not have a clear vision or authority.

Personally investigated the decision-making process for new products, incentives and accountability. Overcame functional silos by establishing and leading an internal Portfolio Management Board. Evaluated executives to decide who should join the Board and persuaded each to do so. Formed a cross-functional team and decision-making process that stopped market share decline and shortened new-production introduction cycles.

The new decision process was so successful that it survived multiple reorganizations and changes throughout management.

Proper Negotiations Increase the Acquisition Offer by 117% Above Initial Offer

The company received a term sheet from a potential acquirer, but wanted a higher valuation. The potential acquirer had a reputation and history of not moving far from the original offer, and the initial offer was not entirely bad, so the company did not want to lose it.

Analyzed the value of the company and presented it to the acquirer. Leveraged existing relationships with key decision makers at the acquirer, networking to understand needs relative to the proposed transaction. Made the executive decision to aggressively counteroffer to reset expectations, substantiated with the higher valuation data.

The investor's final offer was at a rate 117% higher than the initial offer, well above internal expectations.

Big Picture Mindset Leads to Two Successful Spinoffs

A medical device incubator had more than 40 new device and therapy opportunities to pursue with limited funding. However, management was not sure which opportunities were best and there was no comprehensive approach to evaluate each opportunity in its entirety.

Applied a "big picture" mindset, analyzing the market size for all opportunities. Assessed the clinical, regulatory, and commercialization efforts for the largest market segments as well as the time to get a therapy to market and the strength of the IP. Took into consideration the Board and investors' preference for risk, return, and liquidity.

As a result, two new businesses were established as spinoffs of the company.

Identifying and Overcoming Therapy Barriers Achieves 13% European Growth

A device therapy had reached more than $1B in revenue in the US, but continued to struggle in Europe. High pricing was often blamed as the main obstacle, while management was not certain whether to reduce the price.

Worked directly with country managers and sales representatives to assess penetration barriers. Recognized that price reduction while increasing unit sales would not grow revenue. Identified additional barriers, developing guidelines for local teams to focus on physician education, empowering of device physicians in the hospitals, and collaboration with local governments.

As a result, 13% growth was achieved in the Top 5 countries in Europe.

“Your Dream Became My Dream” Leads to Smooth Execution Despite Challenging Times

A large preeminent hospital became a partner with a company in a multi-center clinical trial. However, the institution was known to be slow, process-oriented and bureaucratic. A clinical research coordinator at the institution was critical in navigating its processes and getting things done. The research coordinator got pregnant and unexpectedly had to go on bedrest 3 months earlier than her scheduled leave. The institution could not find a replacement, which meant at least 3-month delay in the clinical trial.

Over previous months developed good relationship with the research coordinator and the whole team at the institution. Encouraged my team to do the same. Explained the potential value the therapy had to patients and informed the institution of the company’s progress. Always responded to the institution’s questions and requests in a timely fashion serving as a role model.

During the research coordinator’s bedrest, she continued to work on our project. She had no obligation to do so from her institution. When asked why she felt so dedicated she responded “somehow your dream became my dream” and she did not want to slow down the important research. Her ongoing help combined with her knowledge of the institution’s policies and culture ensured a smooth execution of the trial.

Executive Insights and Collaborative Style Brings Apple and Traditional MedTech Players to Due Diligence at a MedTech Startup

A CEO of a MedTech company with products on the market had a strong technical background and therapy knowledge, but was light with investor relationship and fundraising. Moreover, the Board felt that they could not get enough information from the CEO while the CEO felt micro-managed by the Board. The company wanted to get interest from strategic investors.

Became a trusted advisor to both the Board and CEO by focusing them on common goals and objectives. Brought industry standards and pros-and-cons analysis on matters of disagreement. Guided the CEO in pitching the company and all communications with investors. Ensured that Board members were timely informed on all the developments.

The company received interest from both new players like Apple and traditional MedTech strategics resulting in due diligence and term sheets.

Global Market Analysis Leads to a New Business

Scientists designed a new device that was less invasive than the existing standard. However, the company was uncertain whether to pursue it and executives were very divided and had strong opinions on the issue.

Assessed the therapy potential in Europe, Asia, and the US, as well as potential emerging markets as well as different therapy alternatives and competition. Analyzed physician reimbursement and market barriers, coming to a recommendation to pursue the therapy and focus efforts on a European launch.

The company pursued the therapy and is currently in development. The decision was validated when a similar therapy conceived and developed by another startup was acquired for $1.35B.

Refocusing the Business Positions Company for Acquisition

Investors and management wanted the company to be acquired, and although the company had been in business since 1999 it could not reach a successful exit. Additionally, the company had three business opportunities it pursued, but did not have sufficient funding for all three and was struggling to prioritize.

Analyzed all aspects of three opportunities and presented results to persuade management that one opportunity did not have potential buyers and would never position the company for acquisition. Demonstrated that another opportunity was too early in development and would require more money than the company had available.

The company ultimately pursued the most promising opportunity and halted spending on other businesses, which drew immediate interest from several potential buyers.

In-Depth Acquisition Analysis Prevents $250M Loss

Management was leaning toward acquiring a $500M public company with complementary products in order to expand its presence in the market space, increase product offerings, and leverage the sales force. The stock had been around $25-28 per share and suddenly dropped to $20. Although considered a good time to buy, the price appeared to be an unfair valuation.

Conducted detailed research on the company's key markets, competitors and clinical and reimbursement risks. Identified that the company was heavily overvalued, and assessed the fair value of the stock to be approximately $9.90 per share. Presented findings to management and persuaded the executive team not to acquire.

Within 10 months, the stock price dropped 51% from $20 to $9.80 while the stock market grew. The recommendation let the company avoid a potential $250M loss.

Leveraging Networks Secures $5M in Angel Financing

The company had made the decision to do an angel investment round and the Board of Directors had a deep network of wealthy individuals. However, despite the Board's network, each member did not want to use personal influence to convince individuals to invest. Additionally, the economic crisis in the US made angel investors more conservative.

Secured introductions by the CEO and various members of the Board, acting as a company spokesperson for potential investors. Clearly articulated the investment opportunity without pushing towards investment. Informed each Board member of all interactions with potential investors to keep comfort levels at ease.

As a result, raised more than $5M in angel financing.

In-depth Strategy and Risk Assessment Secures 100% Approval on Recommendations

The General Manager and executives of a $1B business unit met on a monthly basis to discuss potential deals. Evaluations and investment decisions were made on three public small-cap companies, six clinical trial-stage startups, and eight preclinical stage ventures, each of which were presented during the monthly meetings over the course of 18 months.

Led research and analysis in the preparation of an in-depth review of each opportunity. Overcame strong opinions from the GM of the business unit and his staff by leading discussions and providing clear documentation of potential value and risks.

Approval was secured on all recommendations, leading to significant revenue for the company while preventing unnecessary losses.

Executive Insight and Recommendations Leads to Board Chairman and CEO Position

After a successful exit the CEO was looking for the next engagement and was in discussions to become a Chairman of the Board for another startup, but was uncertain it was the right move. The startup presented numerous issues and risks and success was far from certain.

Worked directly with the CEO, gaining trust as someone who provided insight and demonstrated good judgment. Determined which issues could be fixed with regard to the next position. Developed a company value proposition that resonated with customers. Personally traveled with the CEO to meet with the startup and assess its prospects.

The CEO accepted the Chairman of the Board position and later stepped into the CEO position based on the recommendation provided.

Market Research Leads to Proper Therapy Positioning and Secures Next Financing Round for Commercialization

A new therapy failed a clinical trial and did not get approval in the US, but was approved in Europe. However, the company was unsure how to position the therapy, what market share to expect, and how to differentiate itself from the competition. Additionally, a competitor with a less invasive therapy had emerged, completed a successful clinical trial, and was acquired by a strategic investor for more than $800M.

Interviewed key opinion leaders throughout the US and Europe, analyzing the advantages and weaknesses of the new therapy against the competition. Performed detailed market research, identifying unique benefits of the therapy that resonated with the customer. Forecasted market share and presented findings to the CEO and Executive team.

The company successfully launched its therapy in Europe and secured next round financing for further commercialization.